Plaque Type PsoriasisPhase 1NCT01646567
SHP-141C in Plaque Type Psoriasis
A Phase 1 study testing SHP-141C, Betamethasone Valerate and Calcipotriol in people with Plaque Type Psoriasis, run by TetraLogic Pharmaceuticals at 1 site in Australia.
Trial summary
The purpose of this study is to assess the safety, tolerability and clinical activity of the SHP-141C topical cream formulations in patients with plaque type psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Type Psoriasis
- What is being tested?
- SHP-141C, Betamethasone Valerate and Calcipotriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2012to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate chronic plaque-type psoriasis.
- psoriasis of at least one year.
- Stable disease for at least two weeks prior to the commencement of study treatment.
- One nominated target lesions must have areas of at least 86 x 57 mm2.
- BMI of less than 35 kg/m2. -
Who cannot join
- Dermatological Conditions
- Subjects with erythrodermic, guttate, palmar, plantar or generalised pustular forms of psoriasis.
- Subjects with scalp, palmar or plantar psoriasis only.
- Subjects with any skin condition other than psoriasis, in particular eczema, cutaneous infections, significant sun damage or an inherited skin disorder (other than psoriasis).
- Concurrent Medical Conditions
- History of clinically significant intercurrent disease of any type (other than psoriasis).
Show all 33Show fewer
- A history of moderate or severe asthma during the last 10 years.
- Major chronic inflammatory disease .
- Congenital immunodeficiency or cancer prone syndrome.
- History of abnormal bleeding tendencies or thrombophlebitis, or a history of Hepatitis B, Hepatitis C or HIV infection.
- History of malignancy (other than adequately treated skin carcinoma or carcinoma-in-situ of the cervix).
- Laboratory Status
- Any evidence of organ dysfunction, which is confirmed on re-examination to be clinically significant (i.e. in the opinion of the Medical Officer would jeopardise the safety of the subject or impact on the validity of the study results),
- A creatinine clearance of less than 75 mL/min.
- Liver function test > 1.5 x upper limit of normal other than an isolated bilirubin.
- Hepatitis B surface antigen, Hepatitis C antibody, HIV antibodies.
- Treatment with any of the following within 4 weeks prior to the commencement of study treatment and for the duration of the study:
- Systemic retinoids.
- Immunosuppressant agents (e.g. methotrexate, cyclosporine, azathioprine, thioguanine prednisone, prednisolone, hydroxyurea or mycophenolate mofetil).
- Phototherapy or photochemotherapy.
- High potency topical corticosteroids.
- "Alternative medicine" treatments for psoriasis.
- Prolonged sun exposure or tanning bed use, which may in the opinion of the Investigator, modify disease activity.
- Topical treatment of the 2 target lesions with any of the following within 2 weeks prior to commencement of study treatment and for the duration of the study
- Moderate potency topical corticosteroids.
- Vitamin D analogues and topical retinoids.
- Keratolytics, coal tar and dithranol.
- Concurrent Medications Subjects have received or anticipate receiving a new medicine (prescription, over-the-counter or herbal), given systemically or topically, within 14 days prior to the start of dosing. Subjects may be enrolled if stable on existing therapy (having been on it for at least 60 days) as determined by the Principal Investigator.
- Hypersensitivity History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations or other topical agents. A known hypersensitivity to lignocaine, or all surgical dressings that may be used in the study procedures.
- Females who are lactating, pregnant or planning to become pregnant.
- Drug and Alcohol Abuse History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug and alcohol screen for drugs of abuse and alcohol.
- Psychiatric Disorder History of any psychiatric illness which may impair the ability to provide written informed consent
- Participation in a research study within 30 days of the start of dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Within-Subject Randomised, Placebo-Controlled, Proof of Concept, Comparison Study of SHP-141C Topical Cream in Psoriasis, Using the Microplaque Assay.
The purpose of this study is to assess the safety, tolerability and clinical activity of the SHP-141C topical cream formulations in patients with plaque type psoriasis.
Read the detailed description
Psoriasis is a chronic, relapsing immunoinflammatory disorder. Chronic plaque psoriasis is the most common (85% - 90%) type. Cutaneous features of individual plaques include circular with centrifugal expansion, induration with sharp demarcation from surrounding skin, erythema and hyperkeratosis. Psoriasis has a negative impact on physical and mental aspects of life that is similar to other major chronic conditions. The modalities of psoriasis treatments can be divided into four main categories: topical, phototherapy, systemic drug therapies and systemic biological treatments. The currently available treatments for psoriasis result in either disease suppression or disease remission.There are many treatment options for the management of psoriasis using topical modalities; however all are lacking with respect to patient satisfaction and durability of treatment. Most current topical treatments, and many treatments in development, are based on modifications of a steroid structure or on Vitamin D. Recent research has identified a broad role for histone deacetylase (HDAC) proteins in numerous signaling pathways critical to cancer cell survival, such as epigenetic inheritance, gene regulation, mitosis,signal transduction and importantly, inflammation. Theoretically modulation of HDAC could lead to clinical benefit in inflammatory diseases.
- Conditions
- Plaque Type Psoriasis
- Being tested
- SHP-141C, Placebo to SHP-141C, Betamethasone Valerate, Calcipotriol
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHP-141CDrug
Also called SHAPE
Topical Cream
Placebo to SHP-141CDrug
Also called Placebo to SHAPE
Placebo Topical Cream
Betamethasone ValerateDrug
Also called Celestone-M
Topical cream, 0.02%
CalcipotriolDrug
Also called Daivonex
Topical cream, 0.005%
| Study group | Role | What they receive |
|---|---|---|
| SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate | Experimental | A 100 mg dose of SHP-141C cream at three concentrations (0.5%, 1.0% and 2.0%), a matched placebo cream and two reference treatments: Calcipotriol 0.005% cream and Betamethasone Valerate 0.02% cream, applied topically to a selected plaque on each subject, six times per week over 28 days for a total of 24 doses. Receives: Drug: SHP-141C; Drug: Placebo to SHP-141C; Drug: Betamethasone Valerate; Drug: Calcipotriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Local Plaque Severity Index (LPSI)
Measurement of plaque severity including erythema, induration, and desquamation.
Measured: Baseline, day 15, day 33
Secondary outcomes (1)
The number of patients with adverse events
Adverse event data for each subject will be collected.
Measured: daily to and including Day33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Type PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- TetraLogic Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Foley, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646567
- Sponsor's protocol ID
- SHP-141C-002
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2012
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Within-Subject Randomised, Placebo-Controlled, Proof of Concept, Comparison Study of SHP-141C Topical Cream in Psoriasis, Using the Microplaque Assay.
- ClinicalTrials.gov ID
- NCT01646567
- Acronym / sponsor ID
- SHP-141C-002
- Conditions
- Plaque Type Psoriasis
- Keywords
- psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- TetraLogic PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, tolerability and clinical activity of the SHP-141C topical cream formulations in patients with plaque type psoriasis.
Detailed description
Psoriasis is a chronic, relapsing immunoinflammatory disorder. Chronic plaque psoriasis is the most common (85% - 90%) type. Cutaneous features of individual plaques include circular with centrifugal expansion, induration with sharp demarcation from surrounding skin, erythema and hyperkeratosis. Psoriasis has a negative impact on physical and mental aspects of life that is similar to other major chronic conditions. The modalities of psoriasis treatments can be divided into four main categories: topical, phototherapy, systemic drug therapies and systemic biological treatments. The currently available treatments for psoriasis result in either disease suppression or disease remission.There are many treatment options for the management of psoriasis using topical modalities; however all are lacking with respect to patient satisfaction and durability of treatment. Most current topical treatments, and many treatments in development, are based on modifications of a steroid structure or on Vitamin D. Recent research has identified a broad role for histone deacetylase (HDAC) proteins in numerous signaling pathways critical to cancer cell survival, such as epigenetic inheritance, gene regulation, mitosis,signal transduction and importantly, inflammation. Theoretically modulation of HDAC could lead to clinical benefit in inflammatory diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate | Experimental | Drug: SHP-141C, Drug: Placebo to SHP-141C, Drug: Betamethasone Valerate, Drug: CalcipotriolA 100 mg dose of SHP-141C cream at three concentrations (0.5%, 1.0% and 2.0%), a matched placebo cream and two reference treatments: Calcipotriol 0.005% cream and Betamethasone Valerate 0.02% cream, applied topically to a selected plaque on each subject, six times per week over 28 days for a total of 24 doses. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mild to moderate chronic plaque-type psoriasis.
- psoriasis of at least one year.
- Stable disease for at least two weeks prior to the commencement of study treatment.
- One nominated target lesions must have areas of at least 86 x 57 mm2.
- BMI of less than 35 kg/m2. -
Key exclusion criteria (33 listed)
- Dermatological Conditions
- Concurrent Medical Conditions
- Laboratory Status
- Treatment with any of the following within 4 weeks prior to the commencement of study treatment and for the duration of the study:
- Topical treatment of the 2 target lesions with any of the following within 2 weeks prior to commencement of study treatment and for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHP-141CAlso: SHAPETopical Cream | Drug | SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate |
| Placebo to SHP-141CAlso: Placebo to SHAPEPlacebo Topical Cream | Drug | SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate |
| Betamethasone ValerateAlso: Celestone-MTopical cream, 0.02% | Drug | SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate |
| CalcipotriolAlso: DaivonexTopical cream, 0.005% | Drug | SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate |
Primary outcome
Change from baseline in Local Plaque Severity Index (LPSI)
Time frame: Baseline, day 15, day 33
Measurement of plaque severity including erythema, induration, and desquamation.
1 secondary outcome
The number of patients with adverse events
Time frame: daily to and including Day33
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Foley principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHP-141C, Betamethasone Valerate and Calcipotriol in people with Plaque Type Psoriasis, run by TetraLogic Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Local Plaque Severity Index (LPSI) (time frame: Baseline, day 15, day 33). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014; AzTrials last refreshed its copy on 29 Oct 2026.